MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0701-NT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This is filed to report tissue damage and surgical intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+ with flail, restricted posterior and anterior leaflets, and dense chordae.The first clip (ntw) was advanced to the mitral valve and grasped the leaflets; but the physician was not satisfied with the location.The ntw was moved laterally several times.At some point, the clip got stuck on the anterior leaflet but was able to be freed.The decision was made to remove the device.However, while removing the clip, a small flail was caused.The shaft of the clip was noted to be bent.A second clip (ntw) was inserted.The clip captured the flail and mr looked good.However, the valve looked like it was falling apart.The chords kept popping when grasping.The second ntw was deployed with some residual mr.A third clip (nt) was placed next to the second ntw.In doing so, this caused more of a flail.The valve looked like it was deteriorating.The third clip was implanted.It was noted that there was more mobility on the second clip.The procedure was aborted, and the patient went into surgery for a mitral valve replacement.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, the reported unspecified tissue injury associated with this clip appears to be related to patient condition (condition of the valve) and procedural conditions associated with placement of the clip on the fragile anatomy.Tissue damage is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Surgical intervention, delay to treatment/therapy and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip device referenced in b5 is filed under separate medwatch report number.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16656937
• Report Number: 2135147-2023-01426
• Device Sequence Number: 1700231
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 20324R164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown